Intended Research Applications

This FDA-approved medication combination is provided exclusively as an analytical reference standard for:

• Forensic toxicology studies

• Chromatographic calibration (HPLC/UPLC)

• Pharmaceutical QA/QC testing

• Drug interaction research (in vitro models)

Note: This product contains Schedule III controlled substances. All buyers must provide valid research credentials and comply with 21 CFR 1300.

Key Product Attributes

✔ Authentic Pharmaceutical Product – Direct from licensed US distributor
✔ Fixed 4:1 Ratio – 1.6mg buprenorphine HCl / 0.4mg naloxone HCl per tablet
✔ Batch-Specific CoA – Includes dissolution profile and disintegration data
✔ Regulated Shipping – DEA-approved chain of custody documentation

Technical Specifications

Quality Verification

Each batch undergoes:

• HPLC-DAD quantification against USP reference standards

• Mass spectrometry confirmation (LC-QTOF)

• Dissolution testing (USP Apparatus 2, 50rpm)

• Disintegration verification (<2 minutes in simulated saliva)

Compliance Requirements

Mandatory Buyer Documentation

1. DEA Researcher Registration (Form 225) or

2. Institutional Controlled Substance Authorization

3. End-Use Declaration (Forensic/Pharma Research Only)

Shipping Restrictions

• Domestic: Only to DEA-registered addresses

• International: Not available for export

Why Research Institutions Trust USA CHEM X

✅ DEA-Compliant Sourcing – Verified pharmaceutical supply chain
✅ Chain of Custody – Full documentation from manufacturer to lab
✅ Regulatory Expertise – 21 CFR Part 11 compliant documentation
✅ Research Support – Technical data package included

Legal Disclaimer

This product contains buprenorphine (DEA #9064) and naloxone (DEA #9250), Schedule III controlled substances under the Controlled Substances Act. It is sold strictly to qualified researchers for lawful analytical purposes. Any unauthorized handling violates federal law (21 U.S.C. § 841).

FAQ

1. Can this be used for clinical trials?

No. This is solely for analytical reference – clinical trial materials require different protocols.

2. What’s the shelf life?

36 months when stored in original packaging at controlled room temperature.

3. Do you provide impurity profiles?

Yes – request our extended CoA for related substance data (0.1% LOD).

4. Is animal research permitted?

Only with valid IACUC protocol and DEA Schedule III authorization.

5. How is shipping handled?

Authentic Suboxone 2mg reference material for forensic/research use. USA-sourced, HPLC-verified. Strictly for analytical applications.